Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-3 (Acute inhalation toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Thiram
EC Number:
205-286-2
EC Name:
Thiram
Cas Number:
137-26-8
Molecular formula:
C6H12N2S4
IUPAC Name:
thiram
Details on test material:
- Name of test material (as cited in study report): Thiram Technical
- Physical state: fine white powder
- Analytical purity: 99.5 %
- Lot/batch No.: M.5.1841; G3380
- Stability under test conditions: not provided by the sponsor
- Storage condition of test material: room temperature
- Median particle size: 5.61 µm

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Sprague-Dawley, Inc. Houston, Texas, USA
- Age at study initiation: young adult
- Weight at study initiation: 242-350 g (male), 178-219 g (female)
- Housing: 1-3 per cage, males seperate from females
- Diet (e.g. ad libitum): Purina Formulab Chow # 5008 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least one week

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other: dried filtered air
Analytical verification of test atmosphere concentrations:
yes
Remarks:
determined gravimetrically twice per hour (Andersen cascade impactor)
Duration of exposure:
4 h
Concentrations:
Nominal concentrations: 6.90, 14.1, 32.03 mg/L
Analytical concentrations: 2.06, 3.36, 5.04 mg/L (gravimetric)
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LC50
Effect level:
> 5.04 mg/L air (analytical)
Exp. duration:
4 h
Remarks on result:
other: According to Litchfield and Wilcoxon
Sex:
female
Dose descriptor:
LC50
Effect level:
3.464 mg/L air (analytical)
95% CL:
2.98 - 4.03
Exp. duration:
4 h
Remarks on result:
other: According to Litchfield and Wilcoxon
Sex:
male/female
Dose descriptor:
LC50
Effect level:
4.42 mg/L air (analytical)
95% CL:
3.09 - 6.32
Exp. duration:
4 h
Remarks on result:
other: According to Litchfield and Wilcoxon
Clinical signs:
other: Activity decrease, constricted pupils, gasping, lacrimation, nasal discharge, piloerection, polyuria, ptosis, and salivation.
Gross pathology:
Treatment-related gross necropsy findings: lacrimation, nasal discharge, polyuria, and salivation, discoloration of the contents of the stomach, stomach distended with gas, discoloration of the lungs, and variations thereof.

Any other information on results incl. tables

Dose [mg/L]

Toxicological results*

Duration of clinical signs

Time of death

Mortality (%)

Males

2.06

1/5/5

1/2h - day 7

day 1

0

3.36

1/5/5

1/2h - day 9

day 2

0

5.04

1/5/5

1/2h - day 10

day 1

80

LD50 < 5.04 mg/L

Females

2.06

0/5/5

1/2h - day 7

day 1

0

3.36

2/5/5

1/2h - day 8

day 2

40

5.04

5/5/5

1/2h - day 3

day 1, 2, 3

100

LD50 = 3.464 mg/L

combined LD50 = 4.42 mg/L

* first number = number of dead animals, second number = number of animals with signs of toxicity, third number = number of animals used

Applicant's summary and conclusion